HealthyPhase 1NCT02151617
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
A Phase 1 study testing PF-06743649 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06743649
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.
- Experienced an episode of nephrolithiasis or ureterolithiasis.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety,Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses Of Pf-06743649 With Or Without Food In Healthy Adult Subjects
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated.
- Conditions
- Healthy
- Being tested
- PF-06743649, Placebo
- Keywords
- Multiple dose, safety, tolerability, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06743649Drug
40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
PlaceboDrug
Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
PF-06743649Drug
To be decided dose, tablet once daily dosing for 14 days
PlaceboDrug
Placebo tablet once daily dosing for 14 days
PF-06743649Drug
To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days
PlaceboDrug
Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
PF-06743649Drug
To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days
PlaceboDrug
Placebo tablet one time once without a meal, followed by once daily dosing for 14 days
PF-06743649Drug
Tablet, to be decided dose, once daily, 14 days
PlaceboDrug
Tablet, once daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-PF-06743649 or placebo | Experimental | Subjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3 Receives: Drug: PF-06743649; Drug: Placebo |
| Cohort 2-PF-06743649 or placebo | Experimental | Not described Receives: Drug: PF-06743649; Drug: Placebo |
| Cohort 3-PF-06743649 or placebo | Experimental | Not described Receives: Drug: PF-06743649; Drug: Placebo |
| Cohort 4-PF-06743649 or placebo | Experimental | Not described Receives: Drug: PF-06743649; Drug: Placebo |
| Cohort 5-PF-06743649 or placebo | Experimental | Not described Receives: Drug: PF-06743649; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: up to 14 days
Plasma Decay Half-Life (t1/2)
Measured: up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
Measured: up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
Measured: up to 14 days
Renal clearance (CLr)
Measured: up to 14 days
Secondary outcomes (5)
Change from baseline in serum uric acid level
Measured: up to 14 days
Change from baseline in serum levels of xanthine and hypoxanthine
Measured: up to 14 days
Urinary uric acid levels
Measured: up to 14 days
Urinary xanthine levels
Measured: up to 14 days
Urinary hypoxanthine levels
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151617
- Sponsor's protocol ID
- B7911001
- Status last verified
- Jan 2015
- First submitted
- 28 May 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety,Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses Of Pf-06743649 With Or Without Food In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02151617
- Acronym / sponsor ID
- B7911001
- Conditions
- Healthy
- Keywords
- Multiple dose, safety, tolerability, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-PF-06743649 or placebo | Experimental | Drug: PF-06743649, Drug: PlaceboSubjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3 |
| Cohort 2-PF-06743649 or placebo | Experimental | Drug: PF-06743649, Drug: Placebo |
| Cohort 3-PF-06743649 or placebo | Experimental | Drug: PF-06743649, Drug: Placebo |
| Cohort 4-PF-06743649 or placebo | Experimental | Drug: PF-06743649, Drug: Placebo |
| Cohort 5-PF-06743649 or placebo | Experimental | Drug: PF-06743649, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.
- Experienced an episode of nephrolithiasis or ureterolithiasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-0674364940 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days | Drug | Cohort 1-PF-06743649 or placebo |
| PlaceboPlacebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days | Drug | Cohort 1-PF-06743649 or placebo |
| PF-06743649To be decided dose, tablet once daily dosing for 14 days | Drug | Cohort 2-PF-06743649 or placebo |
| PlaceboPlacebo tablet once daily dosing for 14 days | Drug | Cohort 2-PF-06743649 or placebo |
| PF-06743649To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days | Drug | Cohort 3-PF-06743649 or placebo |
| PlaceboPlacebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days | Drug | Cohort 3-PF-06743649 or placebo |
| PF-06743649To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days | Drug | Cohort 4-PF-06743649 or placebo |
| PlaceboPlacebo tablet one time once without a meal, followed by once daily dosing for 14 days | Drug | Cohort 4-PF-06743649 or placebo |
| PF-06743649Tablet, to be decided dose, once daily, 14 days | Drug | Cohort 5-PF-06743649 or placebo |
| PlaceboTablet, once daily, 14 days | Drug | Cohort 5-PF-06743649 or placebo |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: up to 14 days
Plasma Decay Half-Life (t1/2)
Time frame: up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
Time frame: up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
Time frame: up to 14 days
Renal clearance (CLr)
Time frame: up to 14 days
5 secondary outcomes
Change from baseline in serum uric acid level
Time frame: up to 14 days
Change from baseline in serum levels of xanthine and hypoxanthine
Time frame: up to 14 days
Urinary uric acid levels
Time frame: up to 14 days
Urinary xanthine levels
Time frame: up to 14 days
Urinary hypoxanthine levels
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06743649 in people with Healthy, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: up to 14 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.